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8,982 catalysts · 3,126 8k filing · 1,811 grant · 1,000 device adverse event · 867 approval · 647 device 510k · 584 earnings
8,982 catalysts · 3,126 8k filing · 1,811 grant · 1,000 device adverse event · 867 approval · 647 device 510k · 584 earnings
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1) — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing
Artelon FlexBand Plus Ref: 41054 & 41057 — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12. — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR — Reason: Software anomaly in the patient positioning system may result in positional discrepancy. — Status: Ongoing
GM grant. $446,876. PI: Philippe J. Batut
AI grant. $662,465. PI: David R. Martinez
AI grant. $195,000. PI: Fikadu G. Tafesse
AI grant. $823,143. PI: CLARE Mary BAECHER-ALLAN
DC grant. $685,048. PI: Roy H Hamilton
AI grant. $456,500. PI: LIN CHEN
TR grant. $3,262,377. PI: LINDA G GRIFFITH
EY grant. $860,190. PI: Trevor Jackson McGill
AI grant. $3,144,408. PI: Donna L. Farber
NS grant. $126,735. PI: Amelia Jane Hicks
DK grant. $91,500. PI: Tadashi Takeuchi
AI grant. $436,454. PI: Victor Tkachev
AI grant. $807,044. PI: Stephanie Jost
DE grant. $427,625. PI: Vaishali Kapoor
AI grant. $3,859,259. PI: Andrea Goldberg Edlow
AI grant. $422,698. PI: Yousif Shamoo
AI grant. $452,375. PI: Aimee S Payne
DK grant. $785,969. PI: PETER ARVAN
AI grant. $409,024. PI: Josh Ryan Beck
AI grant. $442,146. PI: Kayvan Zainabadi
AI grant. $423,500. PI: HANS HAECKER
AI grant. $720,021. PI: PARTHO GHOSH
HD grant. $22,786. PI: Lisa M Bebell
AI grant. $661,313. PI: Facundo Damian Batista
AI grant. $828,340. PI: Ivan D'Orso
AI grant. $240,000. PI: Laimonis A. LAIMINS
NS grant. $23,000. PI: Cristopher M Niell
AI grant. $451,000. PI: Bibhuti Bhusan Mishra
NS grant. $250,328. PI: Vincenzo Alessandro Gennarino
AI grant. $249,000. PI: Pei Su
HD grant. $553,065. PI: Lisa M Bebell
AI grant. $835,269. PI: ULRICH H VON ANDRIAN
AI grant. $427,625. PI: Ronit Fraiman
DK grant. $796,742. PI: Stephen Anthony Zderic
AI grant. $412,749. PI: Christopher D Scharer
AI grant. $3,601,712. PI: Alexander Marson
HD grant. $66,310. PI: Lisa M Bebell
Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL
Sponsor: PADAGIS US. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: PADAGIS US. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL
Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL
Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL